As per the FDA press release "the diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety. Innovative health IT products present tremendous potential benefits, including: greater prevention of medical errors; reductions in unnecessary tests; increased patient engagement; and faster identifications of and response to public health threats and emergencies. However, if health IT products are not designed, implemented or maintained properly, they can pose varying degrees of risk to the patients who use them. The safety of health IT relies not only on how a product is designed and developed, but on how it is customized, implemented, integrated and used"